Proton Pump Inhibitors Should Have Black-box Warnings, Group Tell FDA
Acid Reflux / GERD
GastroIntestinal / Gastroenterology
Regulatory Affairs / Drug Approvals
Pharmacy / Pharmacist
Proton Pump Inhibitors Should Have Black-box Warnings, Group Tell FDA
Written by Christian Nordqvist
Published: Wednesday 24 August 2011
email
4
138SHARE
24
Withdrawal from PPIs (proton pump inhibitors) can lead to severe rebound acid secretion, a complication that can force users to become dependent on them - this should be mentioned in a black-box warning, consumer group Public Citizen has told the FDA (Food and Drug Administration). Examples of PPIs include, Dexilant, Vimovo, Prilosec OTC, Prevacid 24-Hr, Zegerid, Zegerid OTC, Prevacid, Nexium, , Prilosec, Protonix, and Aciphex.
Proton Pump Inhibitors, also known as PPIs, are drugs which reduce gastric acid production. They are the most powerful acid secretion inhibitors available today. PPIs are used to treat several conditions, including gastroesophageal reflux disease (GERD), Barrett's esophagus, dyspepsia, gastrinomas and other conditions that cause hypersecretion of acid, laryngopharyngeal reflux, peptic ulcer disease (PUD), prevention of stress gastritis, and Zollinger-Ellison syndrome. High doses of PPIs can increase the risk of bone fractures, as can their long-term use.
Over the last two decades PPIs have become very popular and are now one of the most widely prescribed drugs in the world - in 2009 approximately 119 million prescriptions were dispensed in the USA alone.
Public Citizen says PPIs are frequently prescribed outside their approved uses, such as for the long term treatment of GERD (past the approved time frame) or stress ulcer prophylaxis in noncritical hospitalized patients. Up to two-thirds of all patients taking PPIs are believed not to have a verified indication for the medication. The group adds that in many cases, for those with presumed GERD on PPIs, other less acid-suppressive therapies are effective in treating symptoms, while "in other cases, the medical problem does not even involve acid reflux.".
In a letter to the FDA, Public Citizen wrote:
"Compounding the problem of massive inappropriate use, recent evidence has documented several serious new safety problems with long-term PPI use. For some of these risks, current FDA-approved PPI labels do not mention the adverse effect at all, including the potential for developing dependence on the drugs, which results in rebound hypersecretion of stomach acid and recurrence of symptoms after stopping PPI use.
For other risks, even if mentioned, the label does not adequately explain or emphasize them. There are currently no black box warnings in the label of any PPI.
This petition outlines the current state of evidence of the risks involved with short- and long-term use of PPIs and asks that the FDA make prescribers and consumers aware of these risks through the following labeling changes."
